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Regulations

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FSCA
19Sep 2024
Regulations, Blogs, Swiss admin

Field Safety Corrective Action (FSCA) – Swiss

What is a Field Safety Corrective Action? Any action performed to reduce the risk of death or serious deterioration in health connected with the use of a medical device is referred to as Field Safety Corrective Action (FSCA). The manufacturer is required to take action to remove or limit the risk of the recognised dangers. If a medical device malfunctions in Switzerland, the manufacturer is required to undertake an FSCA and Swissmedic keeps track of all FSCAs regarding medical equipment sold in...
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29Aug 2024
EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin

Global ISO Requirements

What is ISO? ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements. Are ISO standards impor...
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26Aug 2024
EU, Regulations Cubicdesignz

EU Declaration of Conformity

The Declaration of conformity (DoC) is one of the key documents within technical documentation. Technical documentation is necessary for manufacturers as this is a detailed record that provides essential information on the design, manufacture, and operation. EU Declaration of Conformity is signed by the manufacturer to declare that the products comply with the EU requirements. By signing it, the manufacturer takes full responsibility for the product’s compliance with the applica...
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Regulation (EU)
23Jul 2024
Regulations, News admin

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations.  Paragraph 3 Amendments Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that o...
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13Jul 2024
Regulations, Swiss Cubicdesignz

Implant Card for Switzerland

Implant Cards in Switzerland For implantable products, the manufacturer must provide the product information required under Article 16 of MedDO, the information required under Article 18 paragraph 1 EU-MDR and must include the implant card. In Switzerland, the implant card must be in all three official languages of Switzerland. The information regarding implant card is in MedDO Article 20 Information on implantable devices. Healthcare institutions must enter the details of the implant...
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12Jul 2024
EU, Regulations Cubicdesignz

The ‘Blue Guide’ on EU product rules implementation 2022 

The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across various sectors throughout the EU single market. The Blue Guide has undergone significant changes, including the definition of new terms, the addition of information on which economic actors will be responsible for compliance...
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12Jul 2024
EU, News, Regulations Cubicdesignz

Risk Management of medical devices under MDR

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan, document, and implement risk management strategies in this process. These strategies may either eliminate the risk or mitigate the overall severity of the risk. Medical Device Risk- Definition      ...
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12Jul 2024
EU, Regulations Cubicdesignz

Cybersecurity for medical devices in Europe

EU Cybersecurity laws for Medical devices are advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. The importance of protecting patient data from cyber-attacks is now well recognised. With the advancement of software as a medical device, proper regulations must be established to ensure the safety and security...
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12Jul 2024
Blogs, EU, Regulations Cubicdesignz

EU MDR – Language Requirements  

October 2021.   The EU MDR 2017/745 brings more safety to the device in the European market. As part of the Safety measure for the largest medical device market in the world EU Union has made measures to make sure the product sold in the EU market is accessible for everyone at the same time is safe and traceable at every stage of the product lifecycle. The new regulation has made measure that a professional user as well as a lay person can understand the correct usage of the devic...
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12Jul 2024
EU, Regulations Cubicdesignz

In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746

The IVD medical devices Regulation (EU) 2017/746 (IVDR) brings EU legislation into line with technical advances, changes in medical science, and progress in law-making. The new Regulation creates a robust, transparent, and sustainable regulatory framework recognised internationally, improving clinical safety and creating fair market access for manufacturers.  In contrast to the previous Directive, the new Regulation is directly applicable and does not need to be transposed into na...
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